New Trial Tests Whether TB Shot Fights Type 1 Diabetes
New Trial Tests Whether TB Shot Fights Type 1 Diabetes
Researchers will look at effects in people with longstanding disease
But in type 1 diabetes, higher TNF levels appear to lower the attack on the beta cells. And the BCG vaccine causes increased amounts of TNF. Once the immune system attack is dampened, it appears that the pancreas can regenerate at least some insulin-producing beta cells, Faustman said.
She noted that the BCG vaccine has been used to prevent tuberculosis infections for about 90 years, so it has a long record of safety.
The phase 1 trial of the vaccine included six people with type 1 diabetes. The average time the study volunteers had diabetes was 15 years. They were randomly assigned to receive two injections of the vaccine or a placebo. That study lasted 20 weeks.
Two out of three people given the vaccine showed evidence that the vaccine increased the good immune cells and decreased the bad immune cells. The researchers also saw evidence of insulin production.
The new randomized, double-blind trial will include 150 adults between the ages of 18 and 60. Faustman is looking for people who've had type 1 diabetes for a long time, probably around 15 to 20 years. They have to still have some activity in their pancreas. This can be measured with a blood test.
Volunteers will receive two injections, of either the vaccine or a placebo, two weeks apart. Then they'll be given a single injection annually for the next four years. Faustman said initially they'll need to do blood tests every two weeks or so. Eventually, blood tests will only need to be done every six months to once a year, she said.
Although the trial will be done in Boston, Faustman said people don't have to live in the Boston area to be part of the study.
Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said, "It would be very nice if there is any type of response to the BCG vaccine. The vaccine is safe, and it's cheap."
But Zonszein said he has his doubts. "The body is very smart. The mechanisms in the body have so many redundancies, I'm reluctant to believe that selective immunosuppression would reverse type 1 diabetes."
Trial Tests Whether TB Shot Fights Type 1 Diabetes
Researchers will look at effects in people with longstanding disease
But in type 1 diabetes, higher TNF levels appear to lower the attack on the beta cells. And the BCG vaccine causes increased amounts of TNF. Once the immune system attack is dampened, it appears that the pancreas can regenerate at least some insulin-producing beta cells, Faustman said.
She noted that the BCG vaccine has been used to prevent tuberculosis infections for about 90 years, so it has a long record of safety.
The phase 1 trial of the vaccine included six people with type 1 diabetes. The average time the study volunteers had diabetes was 15 years. They were randomly assigned to receive two injections of the vaccine or a placebo. That study lasted 20 weeks.
Two out of three people given the vaccine showed evidence that the vaccine increased the good immune cells and decreased the bad immune cells. The researchers also saw evidence of insulin production.
The new randomized, double-blind trial will include 150 adults between the ages of 18 and 60. Faustman is looking for people who've had type 1 diabetes for a long time, probably around 15 to 20 years. They have to still have some activity in their pancreas. This can be measured with a blood test.
Volunteers will receive two injections, of either the vaccine or a placebo, two weeks apart. Then they'll be given a single injection annually for the next four years. Faustman said initially they'll need to do blood tests every two weeks or so. Eventually, blood tests will only need to be done every six months to once a year, she said.
Although the trial will be done in Boston, Faustman said people don't have to live in the Boston area to be part of the study.
Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, said, "It would be very nice if there is any type of response to the BCG vaccine. The vaccine is safe, and it's cheap."
But Zonszein said he has his doubts. "The body is very smart. The mechanisms in the body have so many redundancies, I'm reluctant to believe that selective immunosuppression would reverse type 1 diabetes."
